FDA Medical Device Recalls (openFDA)
Mckesson Medical Immaging: Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
- Recall number
- Z-1728-2014
- Recalling firm
- Mckesson Medical Immaging
- Product
- Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
- Status
- Terminated
- Initiated
- 2014-05-29
- Posted
- 2014-06-06
- Terminated
- 2017-03-31
- Reason
- Firm received a complaint that an unreported study performed that day could not be opened from the archive.
- Root cause
- Software design
- Action
- McKesson sent an Urgent Field Safety Notice dated May 20, 2014, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were informed that the potentially affected software versions will be corrected without removing the systems from their location. Customers were instructed to distribute the notice to all those within their organization who need to be aware and alert all those affilliated with their organization that are affected by this field safety notice. All customers receiving the Field Safety Notice should contact McKesson Support as soon as possible at 1-800-663-2533 to arrange installation of the software update. Customers with questions should contact the Customer Support Department and ask to speak to their Support Manager.
- Quantity
- 659
- Distribution
- Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY, and Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.
- Lot, serial or model codes
- HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 12.0
- 510(k) numbers
- ["K043146"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3003757840
- Firm city
- Richmond Canada
- Firm state
- British Columbia
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28